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EPA science board says transparency rule restricts use of human health studies


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EPA science board says transparency rule restricts use of human health studies

The U.S. Environmental Protection Agency's Science Advisory Board determined that Administrator Scott Pruitt's science transparency rule "would limit the use of science based on human subject data" and was conducted without consultation from the scientific community.

Members of the SAB wrote in a May 12 memo that they were excluded from the development of the proposed Strengthening Transparency in Regulatory Science rule that would overhaul how the EPA uses science for rulemaking. Pruitt announced the proposal at agency headquarters April 24 surrounded by critics of the EPA's previous use of science and by fellow Republicans.

The SAB reviews the quality and relevance of the scientific and technical information being used by the EPA or proposed as the basis for agency regulations. The administrator appoints members, who typically serve terms of two to three years.

Members of the board learned of the rule through news reports and upon its publication in the Federal Register. After discovering the proposal, the SAB formed a work group to analyze the new rule and will discuss the matter further during a May 31 board meeting, which will be open to the public.

"The rule could have the effect of removing legal, ethical, and peer-reviewed studies of health effects as sources to support the agency's regulatory efforts," the SAB said. "Although the proposed rule cites several valuable publications that support enhanced transparency, the precise design of the rule appears to have been developed without a public process for soliciting input from the scientific community."

A number of critics of the rule have said the EPA's proposal seems to bar the agency from using public health studies that inform critical environmental and health protections. But Pruitt has defended the rule as a transparency measure that will release more information for public scrutiny. At a U.S. House of Representatives hearing in late April, Pruitt said his policy would not prohibit the agency from relying on public health studies, so long as the authors "provide the data and methodology to the agency and the findings."

Assistant Administrator for the Office of Air and Radiation Bill Wehrum, speaking before a May 16 hearing of the House Energy and Commerce Subcommittee on the Environment, said he did not believe that it was necessary for the SAB to review the proposed science rule.

One of the SAB's major functions is to review the EPA's unified agendas, which are released semiannually and lay out the agency's priorities and planned regulatory actions. The science transparency rule was not announced as a planned "major action" in the two agendas released in 2017, the SAB memo said. Nor did the proposal mention the SAB or other advisory boards that typically vet science used for rulemakings.

The SAB said the EPA is usually required to provide the advisors with proposed criteria documents, standards, limitations or regulations plus relevant scientific and technical information upon which a proposed action is based. The board then provides feedback.

"The proposed rule deals with issues of scientific practice and proposes constraints that the agency may apply to the use of scientific studies in particular contexts," the board said. "As such, this rule deals with a myriad of scientific issues for which the agency should seek expert advice from the [SAB]."

The board acknowledged that most scientific fields are moving toward requiring authors to provide public access to data and analytic methods after scientific findings are published. The transparency measures can "detect and discourage scientific fraud, facilitate various forms of robustness analysis, and allow supplementary lines of knowledge to be developed from the same data," said SAB.

But the board has concerns about the EPA's new proposal, including the cost and effort associated with the level of disclosure the agency seems to be seeking. The memo said data from older studies might not be feasible to release, and special considerations need to be made for information that may infringe on legitimate confidentiality and privacy interests. The SAB also said the proposal lacks an assessment of its impacts on existing or future regulatory programs.

"Without access to the restricted data, regulatory programs could become more or less stringent than they otherwise would be, with consequences for both regulatory costs and benefits," the board said. Moreover, the proposal has proven "highly controversial," and "could have long-term implications."

An EPA spokesperson said in a May 16 statement that the SAB "plays an important role in informing EPA actions on policy and regulatory matters."

"We value the board's expertise, and we welcome feedback from the chartered panel on areas in which they are interested in getting additional scientific information that is relevant to the rulemaking process," the spokesperson said.